Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes (DUAL™ I)
|ClinicalTrials.gov Identifier: NCT01336023|
Recruitment Status : Completed
First Posted : April 15, 2011
Results First Posted : June 2, 2017
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/liraglutide Drug: insulin degludec Drug: liraglutide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1663 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension|
|Actual Study Start Date :||May 23, 2011|
|Actual Primary Completion Date :||May 24, 2012|
|Actual Study Completion Date :||November 22, 2012|
Drug: insulin degludec
Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.
Drug: insulin degludec/liraglutide
Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.
Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.
- Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26. [ Time Frame: Week 0, week 26 ]Values of mean change in HbA1c.
- Mean Change From Baseline in Body Weight at Week 26 [ Time Frame: Week 0, Week 26 ]Values of mean change in body weight.
- Number of Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ]Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.
- Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test [ Time Frame: Week 0, Week 26 ]Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.
- Mean Actual Daily Insulin Dose [ Time Frame: Week 26 ]Mean of the actual doses recorded at visit 28 (Week 26).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336023
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|